FDA 483 - Biomat USA Inc - February 04, 2026

An FDA inspection of Biomat USA Inc.'s Source Plasmapheresis Collection Center in Surprise, AZ, revealed significant deficiencies. Observations included a failure to maintain complete donor test records, non-adherence to standard operating procedures for donor arm preparation, and an inadequate SOP for investigating adverse donor reactions. These issues highlight concerns regarding data integrity, procedural compliance, and donor safety.